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Wednesday, July 10, 2019 4:26:37 PM
Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway)
July 12, 2019 9:00 AM – 12:00 PM
U.S Food and Drug Administration White Oak Campus
Building 31, Room 1503 - Great Room 10903 New Hampshire Avenue Silver Spring, MD 20993
ABSTRACT
This meeting is to hear public comments on the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) draft guidance. This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(h), added by section 3042 of the 21st Century Cures Act.
Each public presentation is allotted 10 minutes. Five minutes are allotted following each presentation to offer an opportunity for the panel to ask clarifying questions. Please note that times may vary based on participation and other logistics and are subject to change.
8:00 AM – 9:00 AM 9:00 AM – 9:20 AM
9:20 AM – 9:30 AM 9:30 AM – 9:35 AM 9:35 AM – 9:45 AM
9:45 AM – 9:50 AM 9:50 AM – 10:00 AM 10:00 AM – 10:05 AM 10:05 AM – 10:15 AM
10:15 AM – 10:20 AM 10:20 AM – 10:30 AM
Registration
AGENDA
10:30 AM – 10:35 AM
Introductions and Opening Remarks
Ed Cox, MD, MPH, Director, OAP, OND, CDER, FDA
Public Presentation: John Rex, M.D. Chief Medical Officer, F2G Ltd.
Questions
Public Presentation: Thomas Walsh, M.D., Ph.D., Professor of Medicine, Pediatrics, Microbiology & Immunology, Cornell University
Questions
Public Presentation: Phoebe Mounts, Ph.D., General Counsel, Cormedix
Questions
Public Presentation: Colin McGoodwin, Infectious Diseases Society of America
Questions
Public Presentation: Jack Mitchell, Director of Health Policy, National Center for Health Research
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